System for verifying an item in a package

ABSTRACT

A system verifying an item in a package comprises a package producer and a verifier. The package producer produces a package with a label, wherein the package includes an item each with one or more selected tag identifiers that are placed in a location on the item. The verifier verifies the item using 1) the one or more selected tag identifiers as detected using a spectral measurement or 2) a location or a shape of the one or more selected tag identifiers on the item, and 3) the label as read using a label reader.

CROSS REFERENCE TO OTHER APPLICATIONS

This application is a divisional of co-pending U.S. patent applicationSer. No. 13/158,249, entitled SYSTEM FOR VERIFYING AN ITEM IN A PACKAGEfiled Jun. 10, 2011 which is incorporated herein by reference for allpurposes, which claims priority to U.S. Provisional Application No.61/354,633, entitled SYSTEM FOR VERIFYING AN ITEM IN A PACKAGE filedJun. 14, 2010 which is incorporated herein by reference for allpurposes.

BACKGROUND OF THE INVENTION

A producer or reseller of items (including ingredients and components ofsuch items)—for example a manufacturer, but also including other partiesin the entire supply and distribution chain such as a supplier, awholesaler, a distributor, a repackager, and a retailer—especially, butnot limited to, high-value items, faces counterfeiting of the item.Counterfeiting includes the substitution, dilution, addition or omissionof ingredients or components of the item compared to its intendedproduct specification, as well as misrepresentation or diversion of thepackaged item from its intended course of sale. This leads to loss ofpotential revenue as counterfeit items are sold in the place of the realitem. Also, there can be health or product related damages caused by notusing an authentic item as opposed to a counterfeit—for example, thecounterfeit can perform differently or not at all as compared to anauthentic item. This is particularly acute in industries that can affecthealth and safety such as industries involved with pharmaceuticals,nutritional supplements, medical devices, food and beverages,construction, transportation, and defense.

As international criminal organizations become more sophisticated,existing packaging security is proving inadequate. The complexity ofmany industry supply chains—for example, the supply chain of thepharmaceutical industry—lends itself to entry points for adulterated orcounterfeit product(s), often found in carefully counterfeited andhigh-quality packaging, and sometimes in authentic packaging that haseither been stolen or as part of a repackaging operation.

In complex product supply chains and markets with variable pricing,opportunities for arbitrage exist for unscrupulous parties tomisrepresent product pricing without any change to the underlyingproduct, and thus benefit monetarily, for example, as in returns, rebateor charge-back fraud. Monetary gain or loss to either side of atransaction may also result from errors in record-keeping.

In addition to counterfeiting or product misrepresentation, items thatappear physically identical or similar, for example certain nutritionalsupplements, may actually contain different ingredients or components,but because of similar appearance may be unintentionally packaged orlabeled incorrectly. Even if the items are otherwise identical, they mayhave different properties associated with the particular lot or batchconditions; for example, pharmaceuticals that otherwise appear identicalmay have different expiration dates and be incorrectly labeled due tofailures or limitations in quality assurance protocols to ascertain suchdifferences.

For product development and research, it may be beneficial at times tostudy and authenticate performance of items that appear identical butare made differently to learn whether or how those differences affect anend use. At times, it is important in such studies—for example inclinically masked (or ‘blind’) studies leading to pharmaceuticaldevelopment—to be able to confidently identify the underlying itemwithout revealing the true identity to study participants. In the caseof pharmaceutical development and clinical trials, item-level identityerror may be introduced, for example, at the contract researchorganization that repackages the various product formulations intomasked unit-doses. Much time, cost, and effort goes into statisticalsampling and chemical analyses to verify the true identity of theunit-doses that are ultimately administered.

In the effort to attain positive health outcomes in a morecost-effective and timely manner, healthcare providers need to focus onthe adherence to health regimens, not just the efficacy of specificdrugs. Understanding when, where and how often medicine is prescribed bya doctor, accurately and timely dispensed from a pharmacy, received by apatient, and consumed by the patient is helpful in understanding andverifying the effectiveness of the overall health regimen. Recording andcollecting the data for appropriate analysis and study while also beingable to confirm the underlying identity of the medicine at each stage isimportant to the reliability of the information collected.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the invention are disclosed in the followingdetailed description and the accompanying drawings.

FIG. 1 is a block diagram illustrating an embodiment for a system forverifying an item in a package.

FIG. 2 is a block diagram illustrating an embodiment of a packageproducer.

FIG. 3 is a block diagram illustrating an embodiment of a labeler.

FIG. 4 is a block diagram illustrating an embodiment of a verifier.

FIG. 5 is a block diagram illustrating an embodiment for a system forverifying an item in a package.

DETAILED DESCRIPTION

The invention can be implemented in numerous ways, including as aprocess; an apparatus; a system; a composition of matter; a computerprogram product embodied on a computer readable storage medium; and/or aprocessor, such as a processor configured to execute instructions storedon and/or provided by a memory coupled to the processor. In thisspecification, these implementations, or any other form that theinvention may take, may be referred to as techniques. In general, theorder of the steps of disclosed processes may be altered within thescope of the invention. Unless stated otherwise, a component such as aprocessor or a memory described as being configured to perform a taskmay be implemented as a general component that is temporarily configuredto perform the task at a given time or a specific component that ismanufactured to perform the task. As used herein, the term ‘processor’refers to one or more devices, circuits, and/or processing coresconfigured to process data, such as computer program instructions.

A detailed description of one or more embodiments of the invention isprovided below along with accompanying figures that illustrate theprinciples of the invention. The invention is described in connectionwith such embodiments, but the invention is not limited to anyembodiment. The scope of the invention is limited only by the claims andthe invention encompasses numerous alternatives, modifications andequivalents. Numerous specific details are set forth in the followingdescription in order to provide a thorough understanding of theinvention. These details are provided for the purpose of example and theinvention may be practiced according to the claims without some or allof these specific details. For the purpose of clarity, technicalmaterial that is known in the technical fields related to the inventionhas not been described in detail so that the invention is notunnecessarily obscured.

A system for verifying an item in a package is disclosed. The systemcomprises a package producer and a verifier. The package producerproduces a package with a label. The package includes one or more itemseach with one or more selected tag identifiers that are placed in alocation on the item. The verifier verifies the one or more itemsusing 1) one or more selected tag identifiers as detected using aspectral measurement, 2) the location and/or shape of the tagidentifiers on the item as detected using an imager, and 3) the label asread using a label reader.

In various embodiments, the label is comprised in part of informationabout the packaged items (hereby denoted goods information or goodsinfo) that is useful to authenticate with the item. For example, goodsinfo for medicines may contain dosage information, expiration dates, lotnumbers, etc. Goods information may comprise different types ofinformation depending on the associated item—for example, ingredient(s),stock keeping unit (SKU) number, identifier, physical characteristic(e.g., weight, dimension, volume, etc.), nutrition information, etc.

In various embodiments, the package contains individually identifieditems, the package contains one type of item identified with anidentifier for the one type of item, or any other appropriate mapping ofidentifier(s) and/or item type, or any appropriate item or type of item.For example, each item (e.g., an individual art piece) has anindividually identifiable set of tags or each type of item (e.g., allart pieces of a series of art pieces, a series of lithographicreproductions, etc.) has the same tag. So, that either each individualitem is identifiable because it has a different tag, or all the items ofthe same type have the same tag so that the items of the type cannotindividually be told apart but instead can be differentiated from othertypes of items (e.g., vitamin C tablets as opposed to vitamin D, or alow-dose type of medicine opposed to its higher-dose counterpart, etc.).

In various embodiments, the package comprises a pharmaceutical packagethat includes one or more solid oral dosage forms (SODFs: e.g., tablets,capsules, caplets, powders, crystals, and thin films, etc.), liquids(e.g., creams, gels, liniments, balms, lotions, injectables, andointments, etc.), and/or any other appropriate medicines. The medicineshave one or more added tag identifiers that are added into the outercoating, are distributed on the outer layer of an uncoated medicine(e.g., a SODF), are distributed throughout a SODF or liquid, or anyother appropriate manner of adding a tag identifier. In someembodiments, each tag comprises a rugate filter. In some embodiments,the physical placement is used for identification—for example, the tagsare laid out in a pattern (e.g., geometric shape, bar code, etc.) thatis detectable using an imaging device. In some embodiments, the shapesof the tags are characterized and the characterization is used foridentification.

In various embodiments, the package comprises a pharmaceutical packagethat includes one or more pills, liquids, test strips, transdermalpatches or any other appropriate medicines or medical devices. Themedicines have an added tag identifier that is added into the outercoating, is distributed on the outer layer of an uncoated medicine(e.g., a pill), is distributed throughout a pill or liquid, or any otherappropriate manner of adding a tag identifier. In various embodiments,the package comprises an item—for example, an electronic chip,sub-component, medical devices, an automobile or airplane part, buildingor material supplies, clothing, toys, cosmetics, jewelry, watches, worksof art, currency, tickets, official identification documents, wine, orgourmet food. In some embodiments, the tag comprises a rugate filter. Insome embodiments, the physical placement is used for identification—forexample, the tags are laid out in a shape (e.g., a circle, a square,etc.) or pattern (e.g., checkerboard, bar code, etc.) that is detectableusing an imaging device. In some embodiments, the shape or shapes of oneor more than one of the tags themselves are characterized and thecharacterization is used for identification. In some embodiments,individual tag placement is partially variable due to inclusion of arandom or pseudorandom step in the tag placement process, allowingunique or nearly unique tag placement for each cluster of tags. In someembodiments, the verifier measures the location of one or more tags onan item or label, and from the tag locations and/or shapes produces asignature by means of an algorithm. In some embodiments, the algorithmuses the relative arrangement and/or shape of multiple tags with orwithout a fiduciary mark to produce a single item signature. In someembodiments, the algorithm produces a signature from the location and/orshape of each tag, and then combines the signatures from more than onetag on an item into a single signature. In some embodiments, thealgorithm produces multiple signatures derived from the location and/orshape of one or more tags. In some embodiments, the verifier produces asingle signature from the location and/or shape of one or more tags. Forexample, the use of a tag shape or combination of tag shapes, theplacement of one or more tags in a pattern or arrangement or therelative locations of the one or more tags, or the spectral signature ofa tag or of more than one tag are used alone or in combination todetermine whether or not an item marked with the tag(s) is the authenticitem.

In some embodiments, tags are made of the silica (deemed “generallyrecognized as safe”—or GRAS—by the FDA), rendering them biologicallyinert and edible. Each barely visible tag contains a custom-manufacturedspectral signature chosen from over one billion possibilities, yet eachitem costs only fractions of a penny to label. The unique opticalsignature of each tag can be read by a low cost scanner and be linked toa label in a secure database, where additional information about theitem can be stored, such as referencing a future e-pedigreetrack-and-trace system. Tags comprise a silicon wafer that is etched tohave a spectral code encoded by the etching. The wafer is divided intosmall tags, and the resultant tags contain a complex porousnanostructure that is programmed during electrochemical synthesis todisplay a unique reflectivity spectrum. The tags are then oxidized by ahigh-temperature bake step to turn the crystalline, nanoporous silicontags into amorphous, nanoporous silica. This bake step stabilizes thenanoporous structure against further oxidation (thus stabilizing thespectral signature) and provides for the tags to be characterized as aGRAS excipient. The spectrum is measured via a simple, low-costspectrometer-based reader, then quickly verified against otherinformation printed on the package, such that the medicine and packagingare authenticated together; tampering with either the package, or thecontents, would flag a security violation. The tags can also be used ontheir own acting simply as labels for quality assurance or otherpurposes. Information capacity is projected to potentially reach onetrillion possible unique spectra, using peak number, peak placement,peak rugate phase, and/or peak amplitude as modulation parameters. Thetags are passive, inconspicuous and can be attached to the outside ofmedicines or food products to be read, for example, through clear ortranslucent plastic blister packs, or mixed into medicines or food as aforensic excipient, to be read as part of an investigation or inspectionprocess by authorized security or quality assurance personnel.

In some embodiments, the tag properties comprise:

-   -   More than one billion codes available    -   Inconspicuous size range (20 μm to 150 μm) allows covert or        semi-covert use    -   Made from clear, high purity silica rendering them biologically        inert and edible    -   High temperature resistance—melting point above 1600° C.    -   Passive—no energy input or output    -   Can be used in or on a product, package, label, or security        fiber    -   Can be applied via sprays, coatings, inks, varnishes, or as part        of laminate    -   Can be integrated at a number of manufacturing stages    -   High level of security possible using random tag shapes;        security can be scaled to suit specific product needs    -   Can be made self-authenticating and reduce the costs and        security risks associated with online databases and maintenance    -   Each piece of the silica microtag contains the coded        information, useful for forensics

In some embodiments, a system verifying an item in a package comprises apackage producer and a verifier. The package producer produces a packagewith a label, wherein the package includes an item each with one or moreselected tag identifiers that are placed in a location on the item. Theverifier verifies the item using 1) the one or more selected tagidentifiers as detected using a spectral measurement or 2) a location ora shape of the one or more selected tag identifiers on the item, and 3)the label as read using a label reader. In various embodiments, thespectral measurement measures a number of a reflectance peak, anamplitude of a reflectance peak, a phase of a reflectance peak, or anyother appropriate measurement. In some embodiments, the spectralmeasurement enables the decoding of a number. In some embodiments, theselected tag identifiers comprise silica. In various embodiments, theassociated one or more selected tag identifiers are placed in a pattern,in a bar code, form a shape, or any other appropriate shape or locationfor an identifier.

In some embodiments, the package comprises one or more items, one ormore selected tag identifiers, a package, and a label. Each item of theone or more items has an associated subset of identifiers of the one ormore selected tag identifiers, wherein the subset of identifiers areplaced in a location on one of the one or more items. The one or moreitems are placed in the package. The package includes the label,wherein 1) the label and 2) the location or shape of the one or moreselected tag identifiers on the one or more items or the one or moreselected tag identifiers as detected using a spectral measurement areused to verify the one or more items.

In some embodiments, the system for verifying a type of item in apackage comprises a package producer and a verifier. The packageproducer produces a package with a label, wherein the package includesan item of the type each with an associated one or more selected tagidentifiers that are placed in a location on the item. The verifierverifies the item using 1) placement information of the one or moreselected tag identifiers on the item or 2) the associated one or moreselected tag identifiers as detected using a spectral measurement, and3) the label as read using a label reader. In various embodiments, thespectral measurement measures a number of a reflectance peak, anamplitude of a reflectance peak, a phase of a reflectance peak, or anyother appropriate measurement. In some embodiments, the spectralmeasurement enables the decoding of a number. In some embodiments, theselected tag identifiers comprise silica. In various embodiments, theassociated one or more selected tag identifiers are placed in a pattern,in a bar code, form a shape, or any other appropriate shape or locationfor an identifier.

FIG. 1 is a block diagram illustrating an embodiment for a system forverifying an item in a package. In the example shown, package producer100 produces item 108 and item 110 each with associated tags (e.g., tags104 and tags 106). Tags 104 are placed on item 108 in placement 109.Tags 106 are placed on item 110 in placement 111. In some embodiments,tags 104 and tags 106 are produced in a batch and selected for beingassociated with each item (e.g., item 108 and item 110). In someembodiments, tags are selected based on a tag shape or a characteristicof a tag shape (e.g., a roughness, a size, a shape, etc.). Items areplaced in packaging 112 that includes label 114. In various embodiments,label 114 includes encoded information of one or more of the following:item type, item potency, item name, item stock keeping unit number,spectral response of the tag associated with the item, item shape, tagshape(s), tag placement information, item usage information, or anyother appropriate information.

Verifier 102 also reads tags 104 and tags 106 using a spectral reader ofverifier 102. Tag shape and/or tag placement is read using an imager ofverifier 102. Verifier 102 verifies the authenticity of package 112using information on label 114, spectral reading of tags, tag shapeand/or tag placement information, or any other appropriate information.Linkages of the information in the label, information encoded in thetag, information encoded in the placement, are formed so that incorrectcomponents are detected (e.g., any tampering or substitution isdetected).

FIG. 2 is a block diagram illustrating an embodiment of a packageproducer. In some embodiments, package producer 200 is used to implementpackage producer 100 of FIG. 1. In the example shown, package producer200 comprises identifier adder 202, labeler 204, and packager 206.Identifier adder 202 receives an identifier (e.g., tag(s)) and item(s)and adds the identifier to the item(s). The item with identifier ismeasured by labeler 204 for spectral information from the tag, placementinformation of the tag on the item (e.g., in a pattern, in a code,forming a shape, etc.), and tag shape and/or characteristic information.Labeler 204, based on the information detected from the items and keyand/or goods information, generates a label for a package for the item.Label is added to the package using packager 206.

FIG. 3 is a block diagram illustrating an embodiment of a labeler. Insome embodiments, labeler 300 is used to implement labeler 204 of FIG.2. In the example shown, labeler 300 comprises spectroscopic reader 302,imager 304, and label generator 308. Spectroscopic reader 302 reads oneor more spectra from a tag or tags associated with an item. Imager 304images an item and/or the placement of tags and/or the shape of tags.Information from spectroscopic reader 302 and imager 304 is input tolabel generator 308 along with goods information and a private key. Forexample, first spectroscopic reader 302 reads one or more tag spectraand outputs a number encoded in the reflectance spectra of the measuredtags. By measuring certain spectral properties, such as the number,amplitude, phase, and/or positions of engineered reflectance peaks ineach spectrum, the encoded number is derived (e.g., by using apredetermined mapping between the measured spectral properties and theencoded number). Imager 304 captures an image of the marker and outputsa unique number related to the image. For example, by measuring thepresence or absence of a tag in an inferred grid defined by printedfiduciary printed marks, creating a number from the grid by consideringthe presence of a tag as a 1 and the absence of a tag as 0, andconcatenating each separate row in the grid into a single row, which canbe seen as a binary number. The unique number is then combined with thereflectance-derived number, either by concatenation or anothermathematical process, to create a unique marker ID. The marker ID isthen combined with goods info (again by either concatenation or a morecomplex process) and the result digitally signed using the private key.The label then contains the computed digital signature, marker ID andgoods info.

FIG. 4 is a block diagram illustrating an embodiment of a verifier. Insome embodiments, verifier 400 is used to implement verifier 102 ofFIG. 1. In the example shown, verifier 400 comprises spectroscopicreader 402, imager 404, label reader 406, and verification processor408. Spectroscopic reader 402 reads one or more tags associated with anitem. Imager 404 images an item and/or the placement of tags and/or theshape of tags. Label reader 406 reads label from package. Informationfrom spectroscopic reader 402 and imager 404 and label reader 406 isinput to verification 408 along with goods information and a public key.The verification processor 408 verifies the digital signature using thepublic key of the public/private key pair. If the digital signature isdeemed invalid, a verification failure is detected. Otherwise, theverification processor 408 uses the information from the spectroscopicreader 402 and imager 404 to compute the marker ID as described in theabove description of FIG. 3. If the computed marker ID matches themarker ID read from the label to a sufficient degree defined by anacceptable reader error metric, the verification processor outputs asignal indicating successful verification.

FIG. 5 is a block diagram illustrating an embodiment for a system forverifying an item in a package. In the example shown, package producer500 produces item 506 with associated tags (e.g., tags 504). In someembodiments, tags 504 are produced in a batch and selected for beingassociated with all items (e.g., item 506). In some embodiments, tagsare selected based on a tag shape or a characteristic of a tag shape(e.g., a roughness, a size, a shape, etc.). Items are placed inpackaging 508 that includes label 510. In various embodiments, label 510includes encoded information of one or more of the following: item type,item potency, item name, item stock keeping unit number, a spectralresponse of the tag associated with the item, item shape, tag shape(s),tag placement information, item usage information, or any otherappropriate information.

Verifier 502 also reads tags 504 using a spectral reader of verifier502. Tag shape and/or tag placement is read using an imager of verifier502. Verifier 502 verifies the authenticity of package 508 usinginformation on label 510, spectral reading of tags, tag shape and/or tagplacement information, or any other appropriate information. Linkages ofthe information in the label, information encoded in the tag,information encoded in the placement, are formed so that incorrectcomponents are detected (e.g., any tampering or substitution isdetected).

Although the foregoing embodiments have been described in some detailfor purposes of clarity of understanding, the invention is not limitedto the details provided. There are many alternative ways of implementingthe invention. The disclosed embodiments are illustrative and notrestrictive.

What is claimed is:
 1. A package, comprising: one or more items; one ormore selected tag identifiers, wherein each item of the one or moreitems has an associated subset of identifiers of the one or moreselected tag identifiers, wherein the subset of identifiers are placedin a location on one of the one or more items; and a package, whereinthe one or more items are placed in the package; and a label, whereinthe package includes the label, wherein 1) the label and 2) the locationor shape of the one or more selected tag identifiers on the one or moreitems or the one or more selected tag identifiers as detected using aspectral measurement are used to verify the one or more items.
 2. Apackage as in claim 1, wherein the subset of identifiers are laid out ina pattern.
 3. A package as in claim 1, wherein the subset of identifiersare laid out in a bar code.
 4. A package as in claim 1, wherein thesubset of identifiers are laid out in a shape.
 5. A package as in claim1, wherein the one or more selected tag identifiers comprise silica. 6.A package as in claim 1, wherein the spectral measurement measures anumber of reflectance peaks.
 7. A package as in claim 1, wherein thespectral measurement measures an amplitude of a reflectance peak.
 8. Apackage as in claim 1, wherein the spectral measurement measures a phaseof a reflectance peak.
 9. A package as in claim 1, wherein the spectralmeasurement enables the decoding of a number.
 10. A package as in claim1, wherein the one or more selected tag identifiers comprise silica. 11.A package, comprising: an item of a type; one or more selected tagidentifiers, wherein the item has an associated subset of identifiers ofthe one or more selected tag identifiers, wherein the associated subsetof identifiers are placed in a location on the item; and a package,wherein the item is placed in the package; and a label, wherein thepackage includes the label, wherein 1) the label and 2) the location ora shape of the one or more selected tag identifiers on the item of thetype or the one or more selected tag identifiers as detected using aspectral measurement are used to verify the item of the type.
 12. Apackage as in claim 11, wherein the associated subset of identifiers isplaced in a pattern.
 13. A package as in claim 11, wherein theassociated subset of identifiers is placed in a bar code.
 14. A packageas in claim 11, wherein the associated subset of identifiers form ashape.
 15. A package as in claim 11, wherein the one or more selectedtag identifiers comprise silica.
 16. A package as in claim 11, whereinthe spectral measurement measures a number of reflectance peaks.
 17. Apackage as in claim 11, wherein the spectral measurement measures anamplitude of a reflectance peak.
 18. A package as in claim 11, whereinthe spectral measurement measures a phase of a reflectance peak.
 19. Apackage as in claim 11, wherein the spectral measurement enables thedecoding of a number.
 20. A package as in claim 11, wherein the one ormore selected tag identifiers comprise silica.